The present procedure for the encapsulation of medicament in a gelatin shell is to use two sheets or ribbons of gelatin between which discrete amounts of medicament are deposited. The sheets of gelatin are then cohered about each unit of medicament to define a capsule. For identification purposes, it is common that the two sheets of gelatin are of different colors so that the resulting capsule is two-toned in those colors. This procedure of using gelatin sheets has a number of disadvantages.
First and foremost, there is a substantial amount of wasted gelatin. While those parts of the gelatin sheets, remaining after the portions used to actually form the capsules have been removed, can be salvaged, it is not reusable as all or a part of a product to be ingested. There is danger that these remaining parts may have been contaminated by the medicament and thus ingested by a person not needing the medicament or for whom the medicament might be dangerous. Furthermore, when it is salvaged the colors are mixed. The result is that the gelatin can be sold only for use in a product, e.g. glue, which is not to be ingested. Such other gelatin products are normally made of a much lower quality gelatin and thus gelatin sold for that use has a substantially lower price tag. To sum it up, while the salvaged gelatin can be sold, there is a substantial loss in value of the salvaged gelatin. The amount of gelatin subject to the value loss is in the range of about ten to thirty percent.
Secondly, this conventional process necessitates the use of gelatin having a relatively high water content, for example, about forty percent. After the capsules are formed this water must be removed by drying. The drying process is slow, requiring from thirty-six to ninety-six hours depending on the thickness of the gelatin shell, the humidity conditions, etc. There are substantial costs in this drying, such as the cost of factory space (which is substantial), the direct costs, etc. Efforts to accelerate the drying have proven futile because the resulting capsules are likely to be deformed.
With some medicaments, the requirement that the gelatin have a relatively high water content has an additional disadvantage. This is that the medicament may tend to absorb water from the gelatin. This can have a deleterious effect on the medicament, the dosage, etc.
The present invention pertains to a machine for extruding a rod or column of edible substance or medicament having an annular shell of dough or gelatin and then pinching off that column into individual capsules consisting of the edible substance or medicament encased in the dough or gelatin from the annular shell of the column. The annular shell of the column can be half one color and half a second color, whereby the resulting capsule is two-toned for identification purposes. If desired, additional colors can be produced.
The present invention substantially overcomes the disadvantages discussed above with respect to the conventional process for forming capsules. There is practically no waste which results in a significant monetary saving. When gelatin is used for the shell its water content as extruded can be relatively low, e.g. in the neighborhood of three to ten percent. This greatly reduces the problem of water removal after the capsules are formed and before they are packaged.
I am aware that it has previously been suggested that capsules could be formed by extruding a tube of gelatin into which is injected amounts of a medicament, with the tube being pinched off to form capsules (e.g. U.S. Pat. No. 2,449,139). However, to the best of my knowledge no capsules have been commercially manufactured by any such process and the process discussed initially herein is the one being used commercially at the present time. A principal object of the present invention is to provide a machine which is suitable for commercial use in the manufacture of capsules comprising a medicament encased in gelatin. The machine includes a number of features which permit the manufacturer to produce capsules to his individual requirements and/or desires.
Further objects and advantages will become apparent from the following description and the drawings herein.